37890 Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices

ANNUAL BURDEN ESTIMATES—Continued

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

Estimated Total Annual Burden Hours: 13,746

In compliance with the requirements

of Section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments on: (a) whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarify of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: July 8, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–18658 Filed 7–13–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Relocation of the Dockets Management

Branch; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of June 16, 1998 (63 FR 32888).

The document announced the relocation

and partial closing of the Dockets

Management Branch (DMB). The

document published with an incorrect

zip code. This document corrects that

error.

FOR FURTHER INFORMATION CONTACT:

Jennie C. Butler, Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane,

Rockville, MD 20852, 301–827–6860.

In FR Doc. 98–15878, appearing on

page 32888, in the Federal Register of

Tuesday, June 16, 1998, the following

corrections are made:

1. On page 32888, in the second

column, under ‘‘SUPPLEMENTARY

INFORMATION,’’ in line six, the zip

code is corrected to read ‘‘20852,’’ and

in the second paragraph, in line eleven,

the zip code is corrected to read

‘‘20852.’’

Dated: July 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18691 Filed 7–13–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0481]

Guidance for Industry on 180–Day

Generic Drug Exclusivity Under the

Hatch-Waxman Amendments to the

Federal Food, Drug, and Cosmetic Act;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘180–Day Generic Drug

Exclusivity Under the Hatch-Waxman

Amendments to the Federal Food, Drug,

and Cosmetic Act.’’ The purpose of the

guidance is to inform the public of

FDA’s application of the 180-day

generic drug exclusivity provisions of

the Federal Food, Drug, and Cosmetic

Act (the act) in light of recent court

decisions on the issue.

DATES: Written comments may be

submitted on the guidance document by

October 13, 1998. General comments on

the agency guidances are welcome at

any time.

ADDRESSES: Copies of the guidance are

available on the Internet at ‘‘http://

www.fda.gov/cder/guidance/

index.htm.’’ Submit written requests for

single copies to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your request.

Submit written comments on the

guidance to the Dockets Management

Branch, (HFD–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jerry

Phillips, Center for Drug Evaluation and

Research (HFD–610), 7500 Standish Pl.,

Rockville, MD 20855, 301–827–5846.

SUPPLEMENTARY INFORMATION: A

requirement of FDA’s regulations

implementing the 180-day generic drug

exclusivity provisions of the act has

recently been successfully challenged in

court. Section 314.107(c)(1) (21 CFR

314.107(c)(1)) applies and interprets

section 505(j)(5)(B)(iv) of the act (21

U.S.C. 355(j)(5)(B)(iv)). Section

314.107(c)(1) contains the ‘‘successful

defense’’ provision, which requires an

abbreviated new drug application

(ANDA) applicant to be sued for patent

infringement and to prevail in the

litigation in order to receive the 180-day

period of marketing exclusivity. Two

recent circuit court decisions, Mova

Pharmaceutical Corp. v. Shalala, No.

97–5082, 1998 U.S. App. Lexis 7391

(D.C. Cir. Apr. 14, 1998) and Granutec,

Inc. v. Shalala, No. 97–1873 and No.

97–1874, 1998 U.S. App. LEXIS 6685,

(4th Cir. Apr. 3, 1998), held that the

‘‘successful defense’’ requirement was

not supported by the act. The effect of

these decisions, together with a June 1,

1998, order of the district court in Mova,

is that FDA will not enforce the

‘‘successful defense’’ provisions of

§ 314.107(c)(1).

FDA intends to formally remove the

‘‘successful defense’’ provisions from

§ 314.107(c)(1), but that process is not

complete. Following withdrawal of the

regulatory provision, FDA expects to

begin a rulemaking to issue new
Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices 37891

regulations under section 505(j)(5)(B)(iv)

of the act. In the meantime, the agency

must make exclusivity decisions for

ANDA’s that are nearing approval. Until

such time as the rulemaking process is

complete, FDA will regulate directly

from the statute and will make decisions

on 180-day generic drug exclusivity on

a case-by-case basis.

The guidance is intended to provide

industry with information on how FDA

is applying section 505(j)(5)(B)(iv) of the

act in light of the decisions in Mova and

Granutec. The agency will revise this

guidance as additional interpretations

are made.

The guidance is being implemented

immediately without prior public

comment because the guidance is

needed to explain FDA’s application of

the statute in light of recent court

decisions. However, the agency wishes

to solicit comment from the public and

is providing a 90-day comment period

and establishing a docket for the receipt

of comments.

This guidance is a level 1 guidance

consistent with FDA’s good guidance

practices (62 FR 8961, February 27,

1997). It represents the agency’s current

thinking on 180-day generic drug

exclusivity under the Hatch-Waxman

Amendments. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the act.

Interested persons may submit written

comments on the guidance to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. The guidance and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: July 7, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–18690 Filed 7–13–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995 for

opportunity for public comment on

proposed data collection projects, the

Health Resources and Services

Administration (HRSA) will publish

periodic summaries of proposed

projects being developed for submission

to OMB under the Paperwork Reduction

Act of 1995. To request more

information on the proposed project or

to obtain a copy of the data collection

plans, call the HRSA Reports Clearance

Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project

Grantee Reporting Requirements for

the Rural Health Network Development

Grant Program (OMB NO. 0915–0218)—

Extension.

This is a request for extension of the

reporting requirements for the Rural

Network Development Grant Program

authorized by section 330A of the

Public Health Service Act as amended

by the Health Centers Consolidation Act

of 1996 (Public Law 104–229). The

purpose of the program is to assist in the

development of vertically integrated

networks of health care providers in

rural communities. Grantees will be

working to change the delivery system

in their service areas and will be using

the Federal funds to develop network

capabilities.

Grantees submit semiannual reports

which provide information on progress

towards goals and objectives of the

network, progress toward developing

the governance and organizational

arrangements for the network, specific

network activities, certain financial data

related to the grant budget, and health

care services provided by the network.

The information is used to evaluate

progress on the grants, to understand

barriers to network development in

rural areas, to identify grantees in need

of technical assistance, and to identify

best practices in the development of

provider networks in rural

communities.

The information is also used to begin

to evaluate the impact of networks on

access to care.

To minimize the burden on grantees,

the reports will are submitted

electronically. The estimated burden is

as follows:

Type of respondent Number of respondents

Responses

per respondent

Hours per responseTotal burden

hours

Grantees ........................................................................................................... 40 2 20 1,600

Send comments to: HRSA Reports

Clearance Officer, Room 14–36,

Parklawn Building, 5600 Fishers Lane,

Rockville, MD 20857. Written comments

should be received within 60 days of

this notice.

Dated: July 7, 1998.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 98–18692 Filed 7–13–98; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Program Exclusions: June 1998

AGENCY: Office of Inspector General,

HHS.

ACTION: Notice of program exclusions.

During the month of June 1998, the

HHS Office of Inspector General

imposed exclusions in the cases set

forth below. When an exclusion is

imposed, no program payment is made

to anyone for any items or services

(other than an emergency item or

service not provided in a hospital

emergency room) furnished, ordered or

prescribed by an excluded party under

the Medicare, Medicaid, and all Federal

Health Care programs. In addition, no

program payment is made to any

business or facility, e.g., a hospital, that

submits bills for payment for items or

services provided by an excluded party.